Cutaneous mycoses, also called dermatophytes or tineas, represent the most common fungal diseases in humans. Typical fungal infections in humans may appear as superficial and/or cutaneous presentations characterized by itching, swelling, redness, irritation, skin odor, and/or weeping, cracking or fissuring of the epidermis. Individuals, particularly the elderly or chronically ill and those who are obese, suffer from incontinence, or are immuno-compromised, are especially prone to these types of infections. Most of these infections are chronic and difficult to cure.
Fungal infections are exacerbated by humid conditions that allow the fungi to proliferate. For humans, humid conditions typically develop when moisture in the form of sweat or urine becomes trapped between the clothing and the body and is not effectively wicked away, dried or evaporated from the skin surface. Certain garments such as incontinent products in the form of briefs, pads, pants, shields or undergarments or other products like training pants or diapers can increase the level of humidity in the inguinal groin, perineum and waist regions of the wearer and create optimal conditions for fungal growth. Moisture also can be physically trapped due to reduced air circulation in skinfolds in the perineum, beneath the breast, or in the inguinal area of the groin.
Other common skin flora can also exacerbate cutaneous mycoses by irritating or breaking down the epidermis. For example, bacteria are known to produce chemical byproducts including ammonia, dimethyl sulfide, trimethylamine, and isovaleric acid or other short chain organic acids through the biotransformation of aprocrine sweat, urine and skin proteins. Such byproducts can be quite irritating to the epidermis especially when the skin is already compromised due to dehydration or fungal infection. In addition, these byproducts can be very malodorous causing embarrassment and discomfort for the sufferer and those close to them.
Avoiding the proliferation of fungi and bacteria can minimize the development of common skin irritants and subsequent damage to the skin. Many types of skin care products such as ointments, oil-in-water emulsions, creams, loose powders, and lotions have been used to treat areas of the body that need protection from moisture. Many of these products contain topical anti-fungal agents that, when applied to the skin, can destroy or inhibit the proliferation of the fungi at the root of the infection. Often, these products also include a fragrance or perfume to mask or eliminate unpleasant body odors. However, fragrances or perfumes can be irritating to the skin and can exacerbate compromised skin.
Loose powders have been found to be particularly effective for removing or absorbing moisture from the skin surface. In addition, coating the skin with powdered materials such as corn starch can reduce friction on the skin, due to obesity or shifting or tightness of garments, which can irritate or further exacerbate compromised skin. Furthermore, coating the skin with a loose powder can reduce the probability of adhesion and subsequent colonization of skin fungi and/or bacteria. However, these types of materials often produce a gummy and/or unpleasant feel when exposed to moisture,
Now, an anti-fungal body powder having enhanced excipient properties has been developed. The powder delivers a topical anti-fungal agent to the skin to destroy and/or inhibit proliferation of fungi while minimizing irritation to compromised skin and reducing odor associated with cutaneous mycoses and/or bacterial biotransformation byproducts. The body powder includes a Food and Drug Administration (FDA) approved topical anti-fungal agent that has been proven effective against the types of fungi commonly associated with skin infections. The body powder also includes at least two excipients that enhance the effectiveness and feel of the body powder.
A boron nitride particulate material, desirably in the form of small micronized particles, is coated or impregnated with a silicone compound and is used to reduce and/or prevent adhesion of fungi and bacteria on the skin which in turn reduces colonization of these microorganisms. The silicone coating helps to reduce the perception of grittyness often associated with ceramic powders and provides enhanced slip and lubricity on the skin surface. Additionally, selecting a boron nitride material that has a flat plate particle morphology assists in protecting irritated and/or infected skin. In use, the flat plate particles can order or arrange themselves in closely aligned groups that form a sheet or protectant coating on the skin surface reducing the ability of irritants or fungi from reaching the skin surface.
A fragrance is added to the body powder to assist in reducing the appearance or strength of odors often associated with fungal infections and the biotransformation of apocrine sweat. Because fragrances can be irritating to the skin, especially irritated and/or compromised skin, the fragrance is molecularly entrapped within a cyclodextrin compound to reduce the level of contact between the fragrance and the skin. Additionally, the fragrance usually includes chemicals that are volatile and dissipate over time. Molecularly entrapping the fragrance within a cyclodextrin compound extends the life of the fragrance both in use and in storage. Desirably, the fragrance includes an essential oil that also assists in extending the life of the fragrance and may provide some anti-bacteriostatic functionality.
Preservative compounds and additional excipients such as talc, clays, modified corn starch, acrylic acid co-polymers, maleic acid, stearates, oxides or a combination thereof can be added to the body powder. The preservatives and excipient can further enhance the powder""s ability to absorb moisture, inhibit the formation of malodorous compounds, and inhibit the proliferation of bacteria and fungi. For example, preservatives such as disodium ethylene diamine tetraacetic acid acts as enzyme inhibition chemical by providing chelating agents to block the production of malodorous bacterial byproducts. Talc, clays, and modified corn starches assist in the absorption of sweat and moisture keeping the skin drier and reducing the gummy feel often associated with powders when they become wet. Acrylic acid co-polymers can be used to absorb moisture as well as to regulate the pH of the body powder and impart additional bacteriostatic and/or anti-fungal properties to the body powder. Maleic acid can be used to control the pH of the body powder by offsetting the high pH levels associated with talc.